Clinical trials are research studies that test new treatment and prevention methods to find out if they are safe, effective, and possibly better than the current standard of care (the best known treatment). Clinical trials are designed to accomplish the following:

• Find ways to improve cancer care
  
  
• Answer scientific questions about prevention, diagnosis, and treatment of cancer
  
  
• Determine how well certain treatments work on a particular cancer
  
  
• Determine drug side effects and tolerated dose

Learn more about the basics of clinical trials.

Phases of clinical trials

Clinical research is performed in distinct segments called phases. Each phase of a clinical trial is designed to provide different information about the new treatment, such as the dose, safety, and how well it works. The phases are described as phase I, II, III, and IV.

• Phase I trials determine a safe and optimal dose and schedule of a particular drug. These trials are generally available to people with any type of cancer.
  
  
• Phase II trials determine if a drug is effective in treating cancer.
  
  
• Phase III trials define the role of a drug in cancer treatment. The drug is usually compared with the standard therapy.
  
  
• Phase IV trials are sometimes performed once a drug has been approved to test the drug in a larger population and study how cost-effective it is.

Supportive care trials

Not all clinical trials test new drugs. Supportive care trials look at new treatments to help people manage certain side effects of cancer and cancer treatment, such as anemia or pain.

Older adults and clinical trials

Older adults with cancer have largely been under-represented in clinical trials for several possible reasons:

• Doctors may be reluctant to offer an older individual the possibility of entering a clinical trial.
  
  
• Co-existing medical conditions may render the older individual ineligible for the trial.
  
  
• The older adult may be unable to provide informed consent due to cognitive impairment (such as dementia).
  
  
• The older adult may lack adequate access to transportation.

Patient participation is also affected by several factors such as:

• Age
  
  
• Education
  
  
• Confidence in the doctor
  
  
• Preference for a specific treatment
  
  
• Dislike of experimentation
  
  
• Fear of loss of control
  
  
• Inconvenience
  
  
• Fear of loss of quality of life

Questions to ask your doctor

Clinical trials for older adults may prove to be beneficial. However, older adults with cancer are encouraged to ask the following questions of their doctors before deciding to enroll in a clinical trial:

• What are the risks and benefits of treatment?
  
  
• What costs are covered by the study, and what will I be responsible for?
  
  
• How often will I need to be treated?
  
  
• Are there any additional tests that I will have to complete to be evaluated for the study?
  
  
• How frequent are treatments and follow-up visits?
  
  
• If I participate in a clinical trial, will it make me ineligible for other treatments?
  
  
• How long will the trial be open?
  
  
• How long after completing my current therapy will I be able to participate in the study?
  
  
• How long will it take to evaluate if the treatment is working?

It is important that all treatment options are evaluated, including those available through clinical trials. Again, age alone should not be a factor in determining a person's eligibility for enrollment in a clinical trial. It is important to have open communication with your doctor about what clinical trial treatments are available. Older adults who have co-existing medical conditions should have a caregiver present to help explain the information and requirements. In many cases, written instructions that outline exactly what to expect from the treatment may be helpful.